Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants

March 22, 2022 updated by: Pal Johansen, University of Zurich
The primary objective of the pilot study is to compare inflammatory responses in blood sera from patients receiving first allergen immunotherapy (AIT) with aluminium (Alum), microcrystalline tyrosine (MCT), or a combination of MCT and monophosphoryl lipid A (MPLA) as adjuvants. The AIT products are containing allergen extracts of grass and tree pollen). Blood is collected before as wells as one day, seven days, and 6-7 weeks after first AIT, and the blood is analysed for content of inflammatory proteins and antibodies.

Study Overview

Detailed Description

This pilot study is an observational study with subsequent use of coded biological material. The blood sera are collected and prepared at the Allergy Units at the University Hospital Zurich (USZ) or Centre for Rhinology and Allergology Wiesbaden (AZW). The AZW serum samples will be transferred to USZ for serological analysis. The AIT patients will be allocated to three arms based on their scheduled AIT. Two arms will be allocated to patients at the USZ Allergy Unit, while the last arm is allocated to patients at AZW.

Sixteen study subjects will be recruited from allergy patients that visit the Allergy Unit at USZ to receive AIT as part of standard of care treatment for their allergy. If the patients receive AIT, they can be included in the study. The decision on performing AIT is done by the USZ allergologist, and the therapy itself is not part of the current research project. The 16 USZ patients are split in two study arms. One arm of study subject is scheduled for grass/tree AIT with aluminium-containing "Allergovit", and the second arm is scheduled to receive grass/tree AIT with MCT-containing Polvac.

Eight study subjects will be recruited from allergy patients that visit the AZW to receive AIT as part of standard of care treatment for their allergy. If the patients receive AIT, they can be included in the study. The decision on performing AIT is done by the AZW allergologist, and the therapy itself is not part of the current research project. The 8 patients comprise the third arm of the overall study, and they receive grass/tree AIT with MCT- and MPLA-containing Pollinex Quattro.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8091
        • Univeristy Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients that will be considered for inclusion into the study should have been scheduled for AIT by means of subcutaneous injections of Allergovit® (USZ), Polvac (USZ), or Pol-linex Quattro (AZW), the goal being to include eight patients from each of the three treatment regimens.

Important, the study subjects are only recruited among patients that are to receive their very first AIT. The AIT is not part of the study, but takes place due to prior decisions by the allergologists at USZ or at AZW.

Description

Inclusion Criteria:

  • History of allergy due to IgE sensitisation to any allergen that is treatable by means of AIT, e.g. grass pollen allergens, three pollen allergens, animal dander allergens, dust mite aller-gens, or insect venom allergens.
  • Scheduled to receive first AIT with Allergovit oder Polvac at USZ or to receive Pollinex Quattro at AZW.
  • Signed written informed consent for subsequent use of coded blood samples including blood leukocytes data and serological data.

Exclusion Criteria:

  • Previous AIT
  • Chronic inflammatory diseases (rheumatic diseases, pyelonephritis, osteomyelitis or others)
  • Acute infections
  • Drug or alcohol abuse within the last 5 years
  • Relevant anaemia (as judged by investigator)
  • Blood donation within the last 30 days or during the next 7 days
  • Pregnancy or breast feeding
  • Systemic glucocorticoid or antihistamine therapy within the last 30 days or during the next 7 days.
  • Systemic or local immune drug therapy within the last 30 days during the next 7 days.
  • For linguistic and/or cognitive reasons unable to understand the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grass/tree AIT with Allergovit
Collection of blood and data from patients that receive allergen-immunotherapy (AIT) with Allergovit, an aluminium-containing AIT preparations.
Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis
Grass/tree AIT with Polvac
Collection of blood and data from Patients that receive AIT with Polvac, an MCT-containing AIT preparation.
Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis
Grass/tree AIT with Pollinex Quattro
Collection of blood and data from patients that receive AIT with Pollinex Quattro, an MCT-MPLA containing AIT preparation.
Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in inflammatory proteins in serum after AIT and as assessed using multiplex antibody arrays.
Time Frame: 7 days
The primary objective is to measure a change in inflammatory responses in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. 80-150 inflammatory proteins will be tested using an antibody array. The primary objective of this pilot study is not necessarily to identify single proteins, but to identify patterns of inflammatory proteins that changes over the course of the study and which may be characteristics for the different adjuvants utilized. The results will therefore be described as heat maps with the different proteins presented in fold increase (green colour) or fold decrease (red color) as compared to baseline values.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspartate transaminase in blood after AIT
Time Frame: 7 days
The acute-phase enzyme aspartate transaminase (ASAT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in ASAT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
Alanine aminotransferase in blood after AIT
Time Frame: 7 days
The acute-phase enzyme alanine aminotransferase (ALAT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in ALAT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
Gamma-glutamyltransferase in blood after AIT
Time Frame: 7 days
The acute-phase protein gamma-glutamyltransferase (GGT) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in GGT (in U/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
C reactive protein in blood after AIT
Time Frame: 7 days
The acute-phase protein C reactive protein (CRP) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by standard hospital laboratory methods. The objective is to identify changes in CRP (in mg/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
Interleukin-6 in blood after AIT
Time Frame: 7 days
The acute-phase cytokine interleukin-6 (IL-6) in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in IL-6 (in ng/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
Tryptase in blood after AIT
Time Frame: 7 days
The acute-phase mast cell protein tryptase in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants is analysed by a standard hospital laboratory method. The objective is to identify changes in tryptase (in µg/l) compared to baseline values and which may be characteristics for the different adjuvants.
7 days
Immunoglobulin M (IgM) antibody responses after AIT
Time Frame: Up to 7 weeks
Allergen-specific IgM (in µg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgM is measured by an in-house sandwich ELISA method.
Up to 7 weeks
Immunoglobulin G (IgG) antibody responses after AIT
Time Frame: Up to 7 weeks
Allergen-specific total IgG (in mg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgG is measured by a standard hospital laboratory ELISA method.
Up to 7 weeks
Immunoglobulin G4 (IgG4) antibody responses after AIT
Time Frame: Up to 7 weeks
Allergen-specific IgG4 (in µg/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgG4 is measured by a standard hospital laboratory ELISA method.
Up to 7 weeks
Immunoglobulin E (IgE) antibody responses after AIT
Time Frame: Up to 7 weeks
Allergen-specific IgE (in kU/l) antibody responses will be assessed in sera from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. IgE is measured by a standard hospital laboratory ImmunopCap method.
Up to 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pål Johansen, Prof., PhD, University Hospital Zürich & Unversity of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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